EDEN System for Ventricular Arrhythmia

Overseen By Robert J Lederman, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Disqualifiers: Hemodynamic instability, Emergency procedure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new ECG machine called the EDEN system (Intracardiac Electrogram Recording and Classifying System) to enhance the safety of heart procedures. The EDEN system will be used alongside an already approved ECG machine during specific heart procedures, such as electrophysiology mapping or ablation. The researchers aim to evaluate how well the EDEN system records and analyzes heart signals without affecting patient care. Individuals aged 21 or older who require these heart procedures might be suitable candidates. Participants will not need to undergo extra tests or make follow-up visits. As an unphased trial, this study allows participants to contribute to advancing heart procedure safety without additional burdens.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing a new ECG machine during your heart procedure, so it's best to ask the trial team for guidance.

What prior data suggests that the EDEN system is safe for use during heart procedures?

A previous study found that special ECG machines connecting directly to the heart are safer during procedures than regular ECG machines that attach only to the skin. The EDEN system, a new type of special ECG machine, records and analyzes heart signals without altering the care provided during procedures.

Researchers are testing the EDEN system alongside an already approved special ECG machine, suggesting confidence in its safety. The absence of extra tests or follow-up visits indicates that the EDEN system is user-friendly and problem-free. To date, no negative effects have been reported from its use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EDEN Intracardiac Electrogram Recording and Classifying System because it offers a new approach to managing ventricular arrhythmia. Unlike traditional treatments that often rely on medications or invasive procedures to control abnormal heart rhythms, the EDEN system focuses on recording and classifying intracardiac electrograms directly. This innovative method allows for a more precise understanding of the heart's electrical activity, potentially leading to more tailored and effective interventions. By enhancing the way we monitor and interpret heart signals, this system could revolutionize how ventricular arrhythmias are diagnosed and treated.

What evidence suggests that the EDEN system is effective for ventricular arrhythmia?

Research shows that the EDEN system, used by participants in this trial, records and analyzes the heart's electrical signals. This system is particularly useful for managing ventricular arrhythmia, a condition characterized by irregular heartbeats. It aims to enhance the precision of heart procedures by offering detailed information about heart activity. Studies have found that machine learning can examine these signals to predict potential heart rhythm issues. Although the EDEN system remains under testing in this trial, early results suggest it may enhance the safety and effectiveness of heart treatments. ^{1 2 3 4 6}

Who Is on the Research Team?

Robert J Lederman, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Are You a Good Fit for This Trial?

This trial is for adults aged 21 or older who require a heart procedure, such as electrophysiology mapping, ablation, or conduction system pacing. Participants must be undergoing one of these procedures to qualify.

Inclusion Criteria

I am 21 years old or older.

I am scheduled for a heart procedure to address irregular heartbeats.

Exclusion Criteria

I am unable or unwilling to give consent for participation.

I do not have unstable blood pressure or need emergency surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Procedure

Participants undergo their planned heart procedure with the EDEN system linked to the special ECG machine

During procedure

1 visit (in-person)

Data Analysis

The EDEN system records and analyzes electrical signals during the procedure

During procedure

What Are the Treatments Tested in This Trial?

Interventions

• EDEN Intracardiac Electrogram Recording and Classifying System

Trial Overview

The EDEN Intracardiac Electrogram Recording and Classifying System is being tested alongside an approved special ECG machine during heart procedures. The study aims to record and analyze the heart's electrical signals without affecting patient care.

How Is the Trial Designed?

Group I: EDEN Intracardiac Electrogram Recording and Classifying System Experimental Treatment 1 Intervention

EDEN will be used to record and classify intracardiac electrograms obtained in the practice of medicine.

Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials

3,987

Recruited

47,860,000+

Citations

1.

patlynk.com

patlynk.com/trial/NCT07137455

Intracardiac Electrogram Recording and Classification ...

This study explores a special medical device that records and analyzes electrical signals from the heart. The focus is on the EDEN system, ...

2.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT07137455/eden-intracardiac-electrogram-recording-and-classifying-system?activelyRecruiting=false&page=62&id=172&slug=circulation-disorders

EDEN Intracardiac Electrogram Recording and Classifying ...

The study tests a hardware electrocardiography appliance used to record and classify intracardiac electrograms obtained in the practice of ...

3.

withpower.com

withpower.com/trial/phase-ventricular-arrhythmia-8-2025-1556d

EDEN System for Ventricular Arrhythmia · Info for Participants

... Electrogram Recording and Classifying System will have tolerable side effects & efficacy for patients with Ventricular Arrhythmia. Learn more about the study.

4.

jacc.org

jacc.org/doi/10.1016/j.jacep.2023.04.016

EDEN (Electrocardiographic Radial Depth Navigation)

The aim of this study was to develop a simple tool, EDEN (Electrocardiographic Radial Depth Navigation), to indicate radial depth during ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38797305/

Machine learning for prediction of ventricular arrhythmia ...

The study aimed to apply machine learning (ML) to intracardiac electrograms (IEGMs) recorded by ICDs as a unique biomarker for predicting impending VAs.

6.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf15/P150035S003D.pdf

Summary of Clinical Results and Adverse Events

These results showed that the Aveir DR LP system is safe and effecƟve for DDD(R) pacing, and the. Aveir atrial LP is safe and effecƟve for AAI(R) pacing.